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Treatment of Disseminated High Grade Lymphoma

This study has been completed.
Information provided by:
French Innovative Leukemia Organisation Identifier:
First received: September 26, 2007
Last updated: October 31, 2007
Last verified: September 2007
Interest of the use of pegylated liposomal doxorubicin (caélyx)

Condition Intervention Phase
Drug: Doxorubicin
Drug: Doxorubicin pegylated
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase III Study of Treatment of Disseminated and Agressive Lymphoma R CHOP Versus R CLOP( With Liposomal Doxorubicin)

Resource links provided by NLM:

Further study details as provided by French Innovative Leukemia Organisation:

Primary Outcome Measures:
  • hematologic toxicity [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • response rate [ Time Frame: 6 months ]
  • EFS and OS [ Time Frame: 6 months ]
  • Cardiac toxicity [ Time Frame: 6 months ]

Enrollment: 100
Study Start Date: October 2000
Study Completion Date: October 2004
Arms Assigned Interventions
Active Comparator: Doxorubicine
CHOP 8 courses every 21 days
Drug: Doxorubicin
Experimental: Doxorubicine pegylated
CLOP 8 courses every 21 days
Drug: Doxorubicin pegylated

Detailed Description:
R CHOP is a good standard in the treatment of diffuse high grade lymphoma. Howeverin elderly patients it is often toxic, specially with haematologic and cardiac toxicities.

Ages Eligible for Study:   60 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • high grade lymphoma
  • disseminated
  • > 60 years old and < 75
  • informed consent signed
  • cardiac state compatible with antracyclin
  • ECOG </= 2

Exclusion Criteria:

  • patients > 75 years old
  • Cardiac insufficiency
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00536393

Clinique Victor Hugo
Le Mans, France, 72015
Sponsors and Collaborators
French Innovative Leukemia Organisation
Principal Investigator: Guillaume CARTRON, Dr French Innovative Leukemia Organisation
  More Information Identifier: NCT00536393     History of Changes
Other Study ID Numbers: GOELAMS 0804 
Study First Received: September 26, 2007
Last Updated: October 31, 2007
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by French Innovative Leukemia Organisation:
diffuse larg cells lymphoma
diffuse high grade lymphoma

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on October 21, 2016